Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-04-03
2003-02-11
Look, Edward K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S165030, C604S165020
Reexamination Certificate
active
06517522
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to a tubular intravenous set having various improvements. Such sets are commonly used to gain access to the vascular system of the patient for purposes of blood access for extracorporeal blood processing such as hemodialysis, or for the administration of parenteral solutions, blood, or other medical solutions to the patient.
In the prior art sets for intravenous access to a patient, a medical needle is attached to typically a winged hub, which hub, in turn, is attached to the flexible tubing of the set. The wings of the hub are flexible, being generally folded up, to be gripped by the fingers as the needle is inserted into the vascular system. Then, the wings are folded down and taped to the skin to retain the needle in position.
However, certain drawbacks exist with this system despite its widespread clinical use. For example, if the needle enters the vascular system at an angle that is slightly steeper than normal, the patient may experience discomfort when the wings of the hub are taped down, in that such taping will tend to rotate the needle tip upwardly, resulting in chronic discomfort and even damage to the vein wall while the needle remains in position. Also, the wings are flexible, causing an uncertainty in the process of needle insertion resulting from an absence of rigidity as the wings are gripped.
By this invention, a substantially rigid wing system for the needle hub is provided, which improves the ability of the technician to make an effective and proper entry of the needle into the vascular system. Then, by this invention, the wing member can be removed after the needle has been emplaced, and the needle hub may be taped in position. Alternatively, this invention provides a securance system of the needle hub to the skin in which an angular variation of the needle and hub may be permitted and protected by a rigid system, so that the tip of the needle within the blood vessel is not urged by taping of the hub to the skin into an angular direction that can cause discomfort to the patient and even blood vessel damage.
Additionally, this invention relates to a new design of needle protector sheath for use with preferably wingless needle hubs, in which, after use, the needle can be retracted from the vascular system of a patient, withdrawing into the sheath of this invention so that the sharp tip of the needle is enclosed in the sheath to eliminate the possibility of accidental needle sticks. In the large body of prior art, among others, see Utterberg et al. U.S. Pat. No. 5,112,311; Utterberg U.S. Pat. Nos. 5,562,637; 5,290,264; 5,562,636; 5,951,529; 5,704,917; and Utterberg et al. U.S. Pat. Nos. 5,704,924 and 5,772,638. These patents all disclose needle protector sheaths for use with winged needles, with the sheaths carrying slots through which the wings project.
DESCRIPTION OF THE INVENTION
In accordance with this invention a tubular medical needle set is provided which comprises: a needle and needle hub connected to an end of flexible tubing plus a wing member positioned to facilitate manual gripping of the needle and hub, either by gripping the hub directly or by gripping flexible tubing which is positioned outside of the hub.
The wing member comprises a hub gripping portion (which may grip the tubing adjacent to the hub), and a wall portion attached to the hub gripping portion. The wall portion extends laterally outwardly from the hub gripping portion for manual gripping as the needle is being manipulated. The hub gripping portion is manually disengageable from the hub, for manual removal of the wing member after the needle has been emplaced in a patient. Then, the needle may be directly taped, or may be placed in a tunnel member, which is described below along with the advantages thereof.
Preferably, the wing member comprises a pair of walls and attached hub gripping members which grip the hub, each attached hub gripping member being respectively positioned on an opposed side of the hub to the other hub gripping member. The pair of walls extend in generally parallel, adjacent manner laterally outwardly from the hub, each extending from one of the hub gripping members. The pair of walls define the wall portion described above.
The walls are integrally attached together by a hinge wall. The walls also each define a squeeze portion extending laterally outwardly beyond the hinge wall. Thus, manual squeezing of the squeeze portion disengages the hub gripping members from the hub, to permit removal of the wing member. The hinge wall flexes to an extent, but is biased to force the hub gripping members into their gripping relation.
Preferably, a groove may extend around the needle hub. The hub gripping members may define projections that fit in the groove, to restrict axial sliding of the wing member while gripping the hub. Typically, the groove is defined between the hub and the connected, flexible tubing end carried on the hub.
The wing member may be substantially rigid when mounted on the hub, to be manually gripped as the needle is used in a phlebotomy procedure to enter a blood vessel of the patient. Then, the wing member may be removed. A substantially rigid tunnel member may be applied to enclose at least a portion of the hub resting on the skin of the patient. The tunnel member has a cross section of substantially the shape of an inverted U, to define two tunnel edges for resting on the skin of a patient, while the needle of the enclosed needle hub penetrates the patient's skin.
The tunnel member may have front and rear apertures through which the hub and tubing extend. The rear aperture may be larger than the front aperture, to accommodate a range of angular needle positions in the tunnel member. The tunnel member provides protection and retention to the needle hub, while having a tolerance for a variation in the angle of penetration of the needle through the skin.
The tunnel member may be secured to the skin of a patient by a strip of medical tape, thus securing the needle and hub in position, while permitting the needle and hub to rotate if desired, and protecting the needle and hub even if there is a variation of angle of entrance into the skin, without biasing or otherwise forcing the needle tip to move in an undesirable direction.
To secure the needle and hub longitudinally in position, the front aperture of the tunnel member may at least in part be defined by a front, inwardly extending flange. A groove is defined in the hub, typically the same groove that is engaged by the wing member which may have been previously removed. This groove receives the front flange of the tunnel member, and thus prevents longitudinal movement between the tunnel member and the needle hub. Accordingly, protection of the needle and hub is provided by the tunnel member, while permitting rotatability of the needle and hub about the needle axis, and with tolerance of a variety of needle entrance angles of the needle to the vascular system relative to the skin of the patient.
Further in accordance with this invention, a medical needle protector sheath is provided, which comprises a tubular body for surrounding and shielding a needle. The body has front and rear ends, with the sheath defining a substantially flat anchor member, which is integrally attached to a first attachment portion of the front end of the body, and extends forwardly from the front end of the body, to be manually held to retain the protector sheath from movement as the needle is being withdrawn from the skin of a patient into the tubular body. This has similarity to that which is described in the previously cited Utterberg et al. U.S. Pat. No. 5,112,311 and Utterberg U.S. Pat. Nos. 5,562,637 and 5,772,638.
Additionally, the protector sheath of this invention carries a closure cap for the front end. The cap is also integrally attached to the tubular body. Specifically, the closure cap may be integrally attached to another portion of the front end of the body through a hinged connector member, so that the closure cap may be moved by hinge action to close after t
Bell David
Schnell William J.
Utterberg David S.
DSU Medical Corporation
Garrettson Ellis Seyfarth Shaw
Look Edward K.
White Dwayne
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